Trial · NCT04798339
Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA
NCT04798339, Phase 1, Phase 2, Active not recruiting, H. Lee Moffitt Cancer Center and Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA. Trials, record NCT04798339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04798339
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA
- NCT number
- NCT04798339
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Canakinumab Injection, Darbepoetin Alfa
- First posted
- 2021-03-15
- Last updated
- 2025-10-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Maximum Tolerated Dose (MTD) | up to 28 days per cohort | Maximum tolerated Dose will be determined by testing increasing doses of canakinumab along with a fixed dose of darbepoetin alfa. Patients will be followed for at least 1 cycle before the safety of each cohort can be fully assessed and decisions made for dose escalation in the next cohort. The MTD is defined as the dose level below which DLT is manifested in ≥33% of the patients or at dose level 2 if DLT is manifested in \<33% of the patients (with at 6 patients treated at the MTD). |
| Primary | Phase 2: Rate of Hematologic Improvement-Erythroid (HI-E) response | 8 - 12 weeks from baseline | To determine the rate of hematologic improvement-erythroid (HI-E) response, defined as red blood cell transfusion independence (RBC-TI) of at least 8 weeks in transfusion dependent patients or a mean Hgb increase of \>/=1.5g/dL above baseline sustained for at least 8 weeks in non-transfusion dependent patients. |
| Secondary | Phase 1b and Phase 2: Duration of Hematologic Improvement-Erythroid (HI-E) response | Up to 12 months per cohort | Duration of HI-E response: defined as the total duration for which patient is free from transfusions, or in non-transfusion dependent patients, the duration of sustained Hgb improvement of ./=1.5g/dL above pre-treatment baseline. |
| Secondary | Phase 1b and Phase 2: Degree in reduction of PRBC Transfusions | at 24 weeks per cohort | Degree in reduction of PRBC Transfusions: defined as the total reduction in absolute number of units of PRBCs transfused over the first 24 weeks on study versus the number of units of PRBCs during the 16 weeks prior to treatment |
| Secondary | Phase 2: Overall Response Rate (ORR) | Up to 60 months | Overall Response Rate (ORR) is defined by achieving a complete response (CR), partial response (PR), marrow CR (mCR) or hematologic improvement (HI) by IWG 2006 response criteria in MDS |
| Secondary | Phase 2: Duration of Response | Up to 60 months | Duration of response is defined as the duration that begins on the day patient first achieves a response, until the day that patient loses response/progresses as per IWG criteria or dies. |
| Secondary | Phase 2: Overall Survival (OS) | Up to 60 months | OS is defined as the duration of time starting from first treatment with canakinumab until death |
| Secondary | Phase 2: Progression Free Survival (PFS) | Up to 60 months | PFS is defined as the duration of time starting from first treatment with canakinumab until death or disease progression or transformation, as defined by IWG 2006 criteria. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04798339
GET https://conductscience.org/api/trials/v1/NCT04798339/registered